Named contact care plan for patients undergoing total knee replacement, an intervention development study
| ISRCTN | ISRCTN76980954 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76980954 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 318565 |
| Protocol serial number | IRAS 318565, CPMS 53541 |
| Sponsor | North Bristol NHS Trust |
| Funders | National Institute for Health and Care Research, National Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust, University of Bristol |
- Submission date
- 20/12/2023
- Registration date
- 28/05/2024
- Last edited
- 28/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Over 100,000 knee replacements are done every year in the UK. Most people recover by 3 months after surgery. However, one in five people will have ongoing pain and be dissatisfied with their outcome. Patients can feel abandoned after their knee replacement operation. Some people report a lack of continuity of care and having to tell their story repeatedly to different health professionals. In other medical conditions, patients have a named contact, such as a specialist nurse. They can help people to prepare for surgery, answer questions, check on general health and provide information. This approach may be useful for patients before and after knee replacement.
In this study, the researchers will make a new personalised care plan for patients having knee replacement. They are doing this to help people get the best possible results from surgery. The care plan will be delivered by a named, dedicated healthcare professional. They will help patients to receive the care, support and education they need before and after their operation.
Who can participate?
1. People aged 18 years and over who are on the waiting list for or who have received a primary total knee replacement at a participating NHS Trust.
2. Clinicians involved in the care of people on the waiting list for or who have received a primary total knee replacement.
What does the study involve?
The researchers will set up a group of patients, health professionals and researchers. They will work together to design the care plan. This approach is called co-production and members of the group will be equal partners. To help the group in the design of the care plan, we will do three studies:
1. Collect information from hospitals to understand why operations are cancelled
2. Talk to patients and health professionals about what the care plan should include
3. Do a questionnaire study with patients and health professionals to agree on what should be in the care plan
Findings from these studies will be discussed by the co-production group and used to design the care plan. By the end of the study, the researchers will have a final care plan. They will then apply for funding to do more research to test the care plan and see if it is helpful to patients.
This study was developed with patients. Patients involved in this project will be equal partners in the research, providing input at all stages. The researchers will also work with local community groups to understand how to make the study accessible to people from all backgrounds.
What they find from this work will come out in a variety of formats for researchers, health professionals, and charities.
What are the possible benefits and risks of participating?
Although this study will not benefit participants directly, it is hoped that the results of the study will help build a care plan to help people having knee replacement surgery in the future. Some people also appreciate having an opportunity to share their experiences. A disadvantage is the time it takes to take part.
Where is the study run from?
University of Bristol (UK)
Who is funding the study?
1. National Institute for Health and Care Research (NIHR) (UK)
2. National Institute for Health and Care Research Bristol Biomedical Research Centre (UK)
3. University Hospitals Bristol and Weston NHS Foundation Trust (UK)
4. University of Bristol (UK)
Who is the main contact?
MyKneePlan@bristol.ac.uk
Contact information
Public, Scientific, Principal investigator
Musculoskeletal Research Unit
University of Bristol
Level 1, Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0001-8234-2052 |
|---|---|
| Phone | +44 (0)117 414 7847 |
| Wendy.Bertram@bristol.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Co-production of a care plan delivered by a named contact, providing support and treatment before and after total knee replacement, using data collected from three studies: 1) reasons for cancellation from UK hospitals, 2) qualitative interviews with patients and health professionals, and 3) a modified Delphi study with key stakeholders. |
| Secondary study design | Intervention development |
| Study type | Participant information sheet |
| Scientific title | Named contact care plan for patients undergoing total knee replacement: intervention development |
| Study objectives | What does a named contact care plan before and after total knee replacement (TKR) include when co-produced by researchers, clinicians and patients? |
| Ethics approval(s) |
Approved 05/04/2023, Health and Social Care Research Ethics Committee A (HSC REC A) (Office for Research Ethics Committees Northern Ireland (ORECNI) Lissue Industrial Estate West, 5 Rathdown Walk, Lisburn, BT28 2RF, United Kingdom; +44 (0)28 95 361400; info.orecni@hscni.net), ref: 23/NI/0053 |
| Health condition(s) or problem(s) studied | People waiting for or undergoing total knee replacement |
| Intervention | The researchers will set up a group of patients, health professionals and researchers. They will work together to design the care plan. This approach is called co-production and members of the group will be equal partners. To help the group in the design of the care plan, the researchers will do three studies: 1. Collect information from hospitals to understand why operations are cancelled 2. Talk to patients and health professionals about what the care plan should include 3. Do a questionnaire study with patients and health professionals to agree on what should be in the care plan Findings from these studies will be discussed by the co-production group and used to design the care plan. By the end of the study, the researchers will have a final care plan. They will then apply for funding to do more research to test the care plan and see if it is helpful to patients. This study was developed with patients. Patients involved in this project will be equal partners in the research, providing input at all stages. The researchers will also work with local community groups to understand how to make the study accessible to people from all backgrounds. What they find from this work will come out in a variety of formats for researchers, health professionals, and charities. |
| Intervention type | Other |
| Primary outcome measure(s) |
Care plan components determined using qualitative interviews and questionnaires with patients and health professionals between April 2023 and November 2024 |
| Key secondary outcome measure(s) |
Reasons for cancellation from UK hospitals collected from routinely collected data on planned total knee replacement operations which were cancelled between 01/04/2018 and 31/03/2023 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient, Health professional, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 140 |
| Key inclusion criteria | Patients: 1. Patients aged 18 years and over 2. Patients on the waiting list for or who have received a primary total knee replacement at a participating NHS Trust Clinicians: NHS staff involved in the care of patients waiting for or undergoing primary total knee replacement |
| Key exclusion criteria | Interview study: 1. Lack of capacity to provide informed consent to participate 2. Unable to complete question sheet or interview in the English language 3. Unable to complete interview over the telephone or video call |
| Date of first enrolment | 09/06/2023 |
| Date of final enrolment | 01/09/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| IPD sharing plan | In line with NIHR guidance which encourages the sharing of anonymised datasets (for further information, please see: http://www.journalslibrary.nihr.ac.uk/replace/report-preparation/publication-ethics/3), the researchers will be seeking consent from participants for their data to be shared anonymously with other researchers. Participants who do not wish to consent to this can still participate in the study and their data would be removed before the dataset is archived for potential sharing. The shared dataset will include anonymised transcripts of study two interviews, and the modified Delphi study data. After the study is complete, anonymised data will be shared via the University of Bristol Research Data Repository (https://data.bris.ac.uk/data/). Access to the data will be restricted to ensure that data is only made available to bona fide researchers after a Data Access Agreement has been signed by an institutional signatory. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/05/2024: Study's existence confirmed by the NIHR.
